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The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

The device corresponds to the previously cleared IBA proton therapy system (K101508) with the addition of a compact Gantry Beam line designed to produce and deliver a proton beam from various directions in a range of 220° for the treatment of patients.

The provided text describes a 510(k) premarket notification for a modification to the IBA Proton Therapy System - Proteus 235, specifically the introduction of a Compact Gantry Beam Line (CGBL). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than a comprehensive study report with detailed acceptance criteria and performance data from clinical trials.

Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and comparative effectiveness (MRMC) cannot be fully addressed from the provided text. The document focuses on comparing technological characteristics and functionality to establish equivalence.

Here's an attempt to extract the information based on the provided text, with significant limitations due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison of the modified device (Compact Gantry Beam Line) against the predicate device (360° Gantry Beam Line) for various characteristics. In the context of a 510(k), the "acceptance criteria" are implied by the predicate device's performance, meaning the new device must meet or be substantially equivalent to these values.

Study that proves the device meets the acceptance criteria:

The document states that the "Risk management approach that has been applied for the development of the Compact Gantry Beam Line is described in MID 38870. As described in this document, Risk Analyzes have been performed to identify possible risks associated with the Compact Gantry Beam Line and define appropriate risk mitigations. The main mitigation principles are already applied in the existing beam lines 360°."

It also asserts that "the modified product does not induce changes nor any new limitations for clinical use (and therefore all existing clinical evidence remains valid)."

And concludes: "The new Compact Gantry fulfills the same primary functions as the 360° Gantry... It allows reaching the same clinical performances."

This suggests that the "study" proving the device meets the criteria is primarily an engineering and risk analysis comparison against an existing, cleared device, demonstrating that the changes do not negatively impact performance or safety in the context of its intended use. There is no mention of a
new clinical study with patient data for this 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical test set with patient data for this 510(k) submission. The comparison is based on technical specifications and engineering assessments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a test set requiring expert-established ground truth. The technical specifications are objectively measurable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the clinical sense mentioned in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a radiation therapy system, not an AI or imaging diagnostic aid that would involve human readers. The document details a physical component modification to an existing therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for a clinical ground truth. The "ground truth" in this context refers to the established technical and functional performance of the predicate device (360° Gantry Beam Line) against which the modified Compact Gantry Beam Line is compared through engineering analysis and risk assessment.

8. The sample size for the training set

Not applicable. This device does not use machine learning, therefore, there is no training set mentioned or implied.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for machine learning.

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